Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT01029704

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-07-31

Brief Summary

The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.

The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.

Detailed Description

This was a phase 2 study to evaluate the efficacy of

EGT0001442. The study included two segments:

Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.

Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EGT0001442

Group Type: EXPERIMENTAL

EGT0001442

Intervention Type: DRUG

Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.

Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo capsules to match EGT0001442

Intervention Type: DRUG

Segment 1: Not applicable.

Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.

Interventions

EGT0001442

Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.

Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.

Intervention Type: DRUG

Placebo capsules to match EGT0001442

Segment 1: Not applicable.

Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.

Intervention Type: DRUG

Other Intervention Names

Human SGLT2 inhibitor; Human SGLT2 inhibitor

Eligibility Criteria

Inclusion Criteria

• Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
• Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
• HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
• Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
• Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
• If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
• Female subjects must be surgically sterilized or postmenopausal.

Exclusion Criteria

• Type 1 diabetes or diabetes treated with insulin injection.
• Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
• Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
• Positive results on screen for drugs of abuse.
• Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
• Previous treatment with EGT0001474 or EGT0001442.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theracos

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mason W Freeman, M.D.

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

Research Site #10

Birmingham, Alabama, United States

Research Site #04

National City, California, United States

Research Site #12

Denver, Colorado, United States

Research Site #07

Miami, Florida, United States

Research Site #08

Miami, Florida, United States

Research Site #06

Reading, Pennsylvania, United States

Research Site #11

DeSoto, Texas, United States

Research Site #01

San Antonio, Texas, United States

Research Site #15

San Antonio, Texas, United States

Research Site #03

Brampton, Ontario, Canada

Research Site #13

London, Ontario, Canada

Research Site #02

Mississauga, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

THR-1442-C-402

Identifier Type: -

Identifier Source: org_study_id